European Research and Preparedness Network for Pandemics and Emerging Infectious Diseases

Funding programme: Horizon 2020 (N 101015736)

Budget: €15.7M

Coordinator: Institut National de la Santé et de la Recherche Médicale (INSERM)

Duration: 5 years (Jul 2020 - Jun 2025)

EU-RESPONSE aims to design and run a new adaptive European platform trial on COVID-19 and emerging infectious diseases.

EU-RESPONSE will allow the European expansion of the DisCoVeRy study, a phase III, open-label, adaptive, randomized, controlled, multi-centre clinical trial designed to evaluate the safety and efficacy of medicinal products in hospitalized adult patients diagnosed with COVID-19. The DisCoVeRy trial was originally initiated in France as WHO Solidarity trial “add-on” study and thanks to EU-RESPONSE it will further expand to many other European countries.

Additionally, EU-RESPONSE will allow the building of a new multinational European Adaptive Platform Trial, based on existing initiatives, experiences and competencies – the EU-SolidAct. This will be a flexible platform, providing a modular trial network enabling most, if not all, European hospitals to participate at their preferred level of commitment. EU-SolidAct will aim to run repurposing trials, evaluating combination strategies as well as evaluating efficacy and safety of new compounds entering clinical development on COVID 19. Although in the short-term this project will focus on COVID-19, the mid-term/long-term objectives are to build a platform trial network on emerging infectious diseases in general. The project also includes a coordination module with the EU-funded RECOVER project, led by ECRIN, ensuring complementarity and cooperation across all large European COVID-19 Adaptive Platform trials, and their capacity to answer the needs of society through dialogue with the EMA, national competent authorities, HTAs and industry partners.

ECRIN's role in EU-response : ECRIN provides services to the two adaptive platform trials that are funded within the framework of this project, DISCOVERY and EU SolidAct. ECRIN also coordinates the coordination module that exists between EU Response and RECOVER, where the Trial Coordination Board (TCB), the Joint Access Advisory Mechanism (JAAM) and the Adaptive Platform Trials Toolbox have been established. This coordination module builds a bridge between the DISCOVERY, EU SolidAct, REMAP CAP and ECRAID Prime trials.